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Details for New Drug Application (NDA): 205227

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NDA 205227 describes TEMOZOLOMIDE, which is a drug marketed by Lotus Pharm Co Ltd, Idt Australia Ltd, Mylan Pharms Inc, Sun Pharma Global, Barr, Amerigen Pharms Ltd, Amneal Pharms, and Kremers Urban Pharms, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the TEMOZOLOMIDE profile page.

The generic ingredient in TEMOZOLOMIDE is temozolomide. There are sixteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

Summary for NDA: 205227

Mylan Pharms Inc

Pharmacology for NDA: 205227

Mechanism of ActionAlkylating Activity

Suppliers and Packaging for NDA: 205227

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 205227 ANDA Mylan Pharmaceuticals Inc. 0378-5260 0378-5260-14 14 CAPSULE in 1 BOTTLE, PLASTIC (0378-5260-14)
CAPSULE;ORAL 205227 ANDA Mylan Pharmaceuticals Inc. 0378-5260 0378-5260-98 5 CAPSULE in 1 BOTTLE, PLASTIC (0378-5260-98)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 29, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Jun 29, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jun 29, 2016TE:ABRLD:No

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